Second European Medical Society Endorses Biosimilar Use

A large European medical association has followed on the heels of the European Crohn’s and Colitis Organization, in outlining its support for the use of biosimilars. This time, the European Society of Medical Oncology (ESMO) has endorsed biosimilars for the direct treatment of cancer, seemingly in time for upcoming European approvals. position paper, ESMO acknowledges that a large number of patents will expire for several monoclonal antibodies by 2020, and that in Europe, price reductions could be as high as 40%.

In a press release from ESMO, President Fortunato Ciardiello stated, “Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world.” He added, “Biosimilars give us the chance to make treatment options for cancer more affordable everywhere.”

Although the European Medicines Agency (EMA) does not have a mechanism for approving the interchangeability of biosimilars with the originator drugs, this decision on drug switching is left to the EU member states. In its position paper, ESMO advises member states to “consider the precautionary principle as well as the potential risks associated with substituting a reference biological medicinal product with a biosimilar when tendering for hospitals. Nine out of 28 Member States completely prohibit automatic substitution of biosimilars for reference products by pharmacists. Six out of 28 Member States restrict substitution to ensure the safety of patients and in particular, avoid unforeseen immune responses. There is no clear consensus among Member States concerning this issue, implying that countries may decide whether to implement policies related to automatic substitution or not.”

However, ESMO advises that automatic substitution should be avoided, and switching allowed only if “(1) the physician is well-informed about the products; (2) the patient is fully briefed by the physician and (3) a nurse is closely monitoring the changes and tracking any adverse events.”

The EMA is currently considering the approval of biosimilar rituximab for its oncology indications in addition to rheumatoid arthritis, and trastuzumab for the treatment of breast cancer.